FDA to review safety of ‘breathable caffeine’


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[caption id="attachment_5390" align="alignleft" width="94" caption="Photo credit: AeroShot.com"][/caption]

UPDATE: The FDA announced on March 6 that it had issued a warning letter to the manufacturer of AeroShot caffeine inhalers, Breathable Foods, for "false or misleading statements" in its product's promotional material.

The FDA was concerned with Breathable Foods' contradictory statements that AeroShot was "breathable energy" but was "intended to be ingested by swallowing," explaining that it's impossible for a product to be ingested both ways at once.

The warning letter also expressed concern about whether or not AeroShot was being marketed as a supplement to alcoholic beverages for teens in order to increase energy and continue partying for a longer period of time. Breathable Foods intends on cooperating with the FDA.

For the first time ever, Starbucks might actually have some competition — unless the Food and Drug Administration has something to say about it. The FDA is investigating the safety of Breathable Foods' AeroShot, a lipstick-sized canister filled with lime-flavored “airborne energy” that allows consumers to breathe in caffeine.

It hit the market in January in Massachusetts and New York and is currently sold as a dietary supplement at convenience stores, mom-and-pop stores, liquor stores and online, though the FDA will be reviewing whether or not it should be branded as a dietary supplement.


What is it?
AeroShot’s delivery is similar to that of an asthma inhaler: Consumers place one end of the canister in their mouths and inhale. A fine powder containing B vitamins, a stevia sweetener and 100 mg of caffeine (per canister) — the equivalent of a large cup of coffee — is released and dissolves almost instantly in the mouth. The creator, Harvard biomedical engineering professor David Edwards, advertises the product on its website as “the energy of the future” and emphasizes that it’s completely calorie-free.

He also claims that it’s completely safe. The website states that “AeroShot Energy complies with all FDA dietary supplement regulations. When used in accordance with its label, AeroShot provides a safe shot of caffeine and B vitamins for ingestion. Caffeine has been proven to offer a variety of potential benefits for health to individuals when consumed in moderation, from providing energy to enhancing attention and focus.”


While the product’s packaging advises consumers to not consume more than three AeroShot canisters per day, the website boasts that “there’s no liquid to slow you down or fill you up” — which seems to be the detail with which New York Sen. Charles Schumer has taken issue. AeroShot was not previously reviewed by the FDA because caffeine and B vitamins are legal substances in foods, but in December, Sen. Schumer wrote a letter to FDA commissioner Margaret Hamburg regarding the product’s safety and its potential for abuse.

He wrote: “This product is nothing more than a party enhancer, designed to give users the ability to drink until they drop, and it promotes dangerously excessive consumption of caffeine among youngsters and teens. The product has never been tested for safety by the FDA, particularly among children and teens, and there are absolutely no controls on who can purchase it and how much they can ingest.”


Four Loko's replacement?
Schumer’s letter has led to media comparisons between AeroShot and Four Loko, the caffeinated alcoholic beverage that Schumer helped remove from the market following widespread reports of consumers being hospitalized after drinking the beverages. A group of U.S. state attorneys general voiced concerns that the drink could pose health risks by masking feelings of intoxication, and opponents of the drink complained that it was being marketed toward the underage crowd.

The obvious difference is that this product doesn’t actually contain the alcohol, and Edwards stresses that it's targeting an adult demographic. A more similar product, which seems to have evaded media attention in the coverage of this story, is Sheets Energy strips. Similar in form to Listerine strips for fresh breath, Sheets Energy strips dissolve on the tongue and provide 100 mg of caffeine — the same amount as one of the AeroShot canisters — plus vitamins E, B5, B6 and B12. The product was launched last year by PureBrands, a company co-founded by LeBron James. If the FDA decides AeroShots’ breathable caffeine isn’t safe, what about caffeine strips?


Tell us: Where should the FDA draw the line between safe and potentially dangerous forms of caffeine delivery?